Inspire Upper Airway Stimulation System: Implant of the Inspire Upper Airway Stimulation System
Study summary
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
Eligibility
Sex
ALL
Min age
18 Years
Max age
21 Years
Healthy volunteers
No
Inclusion Criteria:
1. Subject is between 18 and 21 years of age;
2. Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
3. Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
4. Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
5. Subject has followed standard of care in considering all other alternative/adjunct therapies;
6. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
7. Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the registry;
8. Subject is willing and able to provide informed consent.
Exclusion Criteria:
1. Subject has a combination of central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
2. Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
3. Subject has any condition or procedure that has compromised neurological control of the upper airway;
4. Subject is unable, or does not have the necessary assistance, to operate the patient remote;
5. Subject is pregnant or plans to become pregnant;
6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
7. Subject has a terminal illness with life expectancy \< 12 months;
8. Any other reason the investigator deems the subject is unfit for participation in the registry.
Primary outcome measure(s)
Evaluation of device and/or procedure related adverse events over time — Implant through 5 years post-implant relevant adverse events will be collected and reported
Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time — through 5 years post-implant Baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits). The Apnea Hypopnea Index (AHI) is the number of apnea and hypopnea events per hour of sleep. A lower AHI indicates less severe sleep apnea.
Trial sites (8)
Facility
City
Region
Status
Childrens Hospital of Colorado
Aurora
Colorado
Recruiting
Children's Healthcare of Atlanta
Atlanta
Georgia
Terminated
Duke University
Durham
North Carolina
Recruiting
Cincinnati Childrens Hospital
Cincinnati
Ohio
Recruiting
Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
Recruiting
Children's Hospital of Pittsburgh
Sewickley
Pennsylvania
Recruiting
University of Texas Southwestern/Children's Hospital of Dallas
Dallas
Texas
Recruiting
Children's Hospital of the King's Daughters/East Virginia Medical School
Norfolk
Virginia
Recruiting
More Inspire Medical Systems, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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